Case 3:17-cv EMC Document 30-1 Filed 10/25/17 Page 1 of 19

Transcription

1 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 MICHAEL E. WALL (SBN 0 AVINASH KAR (SBN 00 Natural Resources Defense Council Sutter Street, st Floor San Francisco, CA 0 Tel.: ( 00 / Fax: ( mwall@nrdc.org Attorneys for Proposed Amici Curiae Natural Resources Defense Council and Safer Chemicals, Healthy Families FOOD & WATER WATCH, INC., et al., v. Plaintiffs, U.S. ENVIRONMENTAL PROTECTION AGENCY, et al. Defendants. UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA Case No. cv 0 EMC [Proposed] Amicus Curiae Brief of Natural Resources Defense Council and Safer Chemicals, Healthy Families in Support of Neither Party Case No. cv 0 EMC

2 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 TABLE OF CONTENTS TABLE OF AUTHORITIES... ii INTRODUCTION... STATUTORY BACKGROUND... ARGUMENT... I. Section does not require that a petition evaluate every II. III. IV. use of a chemical... EPA s claim that a section petition must evaluate conditions of use that the petitioner has not asked EPA to regulate is neither reasoned nor reasonable... EPAʹs inflated and unsubstantiated concerns about unmanageability do not justify reading additional requirements into section...0 Alternatively, because section judicial review is de novo, a petition need not include all evidence the petitioner will introduce in court... CONCLUSION... Case No. cv 0 EMC i

3 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 Adams Fruit Co. v. Barrett, Case No. cv 0 EMC TABLE OF AUTHORITIES Cases U.S. (0... Am. Bus Ass n v. Slater, F.d (D.C. Cir Baker Botts L.L.P. v. ASARCO LLC, S. Ct. (0...0 Chevron U.S.A. v. Nat. Res. Def. Council, Inc., U.S. (... Doe v. United States, F.d (D.C. Cir.... Envtl. Def. Fund v. Reilly, 0 F.d (D.C. Cir. 0...,,, Gen. Dynamics Land Sys., Inc. v. Cline, 0 U.S. (00... Iselin v. United States, 0 U.S. (... Kaufman v. Allstate N.J. Ins. Co., F.d (d Cir Lamie v. U.S. Tr., 0 U.S. (00... Meister v. U.S. Dep t of Agric., F.d (th Cir Nurses for Healthy Env ts v. EPA, No. (th Cir. filed Aug., 0... Safer Chems. Healthy Families v. U.S. EPA, No. (th Cir. filed Aug. 0, 0... ii

4 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 Saunders v. United States, 0 F.d (th Cir.... Wong v. United States, F.d, (th Cir...., Case No. cv 0 EMC Statutes and Regulations U.S.C. 0(b(... U.S.C. 0((A... U.S.C. 0(... U.S.C. 0(0... U.S.C. 0(a...,,,, 0 U.S.C. 0(a(... U.S.C. 0(b(... U.S.C. 0(b((A... U.S.C. 0(b((C(ii... U.S.C. 0(b((E(i... U.S.C. 0(b((E(ii... U.S.C. 0(c(... U.S.C. 0(e... U.S.C. 0(h... U.S.C. 0(i... U.S.C. (a((b(i..., U.S.C. 0(a..., U.S.C. 0(b(...,,,,, U.S.C. 0(b(..., U.S.C. 0(b((B... U.S.C. 0(b(... iii

5 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 U.S.C. 0(b(... U.S.C. 0(b((A... U.S.C. 0(b((A (B... U.S.C. 0(b((B...,,,, 0, U.S.C. 0(b((B(ii...,,, Fluoride Chemicals in Drinking Water; TSCA Section Petition; Reasons for Agency Response, Fed. Reg., (Feb., 0... Frank R. Lautenberg Chemical Safety for the st Century Act, Pub. L. No., 0 Stat. (0... H.R. Conf. Rep. No. (... Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act: Proposed Rule, Fed. Reg. (Jan., 0...,, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act: Final Rule, Fed. Reg., (July 0, 0...,, 0 Legislative History S. Rep. No. (... S. Rep. No. (0...,, Case No. cv 0 EMC iv

6 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 Case No. cv 0 EMC INTRODUCTION Section of the Toxic Substances Control Act (TSCA authorizes any person to petition the U.S. Environmental Protection Agency (EPA to promulgate a rule to regulate, under section (a of the Act, chemicals that pose unreasonable risks of injury to health or the environment. U.S.C. 0(a, 0(a. Section deputizes the public to ensure that bureaucratic lethargy does not prevent the appropriate administration of [TSCA s] vital authority. Envtl. Def. Fund v. Reilly, 0 F.d, (D.C. Cir. 0. To that end, Congress empowered citizens to petition EPA to address known unreasonable risks from chemicals, without waiting for the agency to evaluate whether all uses of the chemical present unreasonable risks. Congress imposed only one substantive requirement for a section citizen petition : the petition must set forth the facts which it is claimed establish that [the section (a rule] is necessary. U.S.C. 0(b(. Section (a, in turn, provides for EPA to issue a rule restricting or otherwise regulating the use of a chemical upon a finding that the chemical presents an unreasonable risk of injury to health or the environment. Id. 0(a. Consistent with this standard, section (b provides that, if EPA denies such a section petition, a district court may order EPA to initiate the rulemaking if the petitioner demonstrates to the satisfaction of the court in a de novo proceeding that the chemical presents an unreasonable risk to health or the environment. Id. 0(b((B. Read together, section and section (a require that a petition for a new section (a rule includes the facts which [the petitioner] claim[s] establish that, id. 0(b(, the chemical presents an unreasonable risk to health or the environment, id. 0(a, 0(b((B(ii. TSCA requires nothing more. EPA asks this Court to read into section an extra requirement: that the petition evaluate all potential risks posed by other uses of the chemical including uses that the petitioner neither contends pose an unreasonable risk nor asks EPA to restrict. Section

7 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 does not require that information, however, because these are not facts the petitioner claim[s] establish that [the section (a rule] is necessary. Id. 0(b(. Reading into section an additional requirement that petitioners undertake comprehensive risk evaluations like those EPA must conduct under section (b would, by judicial fiat, alter the meticulously described petitioning scheme that Congress set out. Reilly, 0 F.d at 0. Requiring section petitions to evaluate all of a chemical s uses for risk would also make the petition process essentially unavailable to a member of the public who lacked the resources of a large federal agency. Rather than checking EPA s bureaucratic lethargy, id. at, section would become a dead letter. Although EPA requests Chevron deference for its revisionary approach to section, such deference is not warranted where Congress has expressly established the Judiciary and not the [agency] as the adjudicator of private rights of action arising under the provision. Adams Fruit Co. v. Barrett, U.S., (0. But [e]ven for an agency able to claim all the authority possible under Chevron, deference to its statutory interpretation is called for only when the devices of judicial construction have been tried and found to yield no clear sense of congressional intent. Gen. Dynamics Land Sys., Inc. v. Cline, 0 U.S., 00 (00 (citing Chevron U.S.A. v. Nat. Res. Def. Council, Inc., U.S., n. (. An agency is not entitled to deference simply because it is an agency. Meister v. U.S. Dep t of Agric., F.d, (th Cir. 00. To earn that respect, the agency must apply rather than disregard the relevant statutory and regulatory criteria. Id. EPA s brief fails to do that: it disregards statutory text, ignores structural obstacles, and overlooks judicial precedent that is inconveniently inconsistent with its approach. This Court should not accept EPA s invitation to revise section. Amici take no position on the remaining issues raised by EPA s motion to dismiss or the specific petition at issue in this litigation. Case No. cv 0 EMC

8 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 Case No. cv 0 EMC STATUTORY BACKGROUND Congress enacted the Toxic Substances Control Act in to grant EPA the ability to regulate chemical substances and mixtures which present an unreasonable risk of injury to health or the environment. U.S.C. 0(b(. To implement this mandate, TSCA section (a directs EPA to adopt restrictions and other regulations as necessary to prevent such chemicals from posing unreasonable risks. Id. 0(a. Following a quarter century during which EPA had not regulated a single chemical under section (a, S. Rep. No., at (0, Congress amended TSCA in 0. See Frank R. Lautenberg Chemical Safety for the st Century Act, Pub. L. No., 0 Stat. (0. As amended, EPA s duty to promulgate a section (a rule may arise in one of at least three ways. First, under section (b, EPA must conduct comprehensive risk evaluations to decide whether chemicals present unreasonable risks to health or the environment under the chemicals conditions of use. U.S.C. 0(b((A. However, contrary to the implication of EPA s brief, compare Mot. to Dismiss, EPA s section (b risk evaluations are conducted not only on chemicals that EPA has identified as high priority, see U.S.C. 0(b(, but also on non priority chemicals that manufacturers ask EPA to evaluate, see id. 0(b((C(ii. Indeed, up to half of the risk evaluations that EPA conducts must be in response to such a manufacturer request. Id. 0(b((E(i. Although TSCA applies to chemical substances, U.S.C. 0((A, and mixtures, id. 0(0, this brief refers to both as chemicals for brevity. Conditions of use means the circumstances... under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. U.S.C. 0(. This brief refers to uses of a chemical when referring to such conditions of use.

9 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 When EPA finds that a use of a chemical presents an unreasonable risk following a comprehensive section (b risk evaluation, EPA must restrict that use under section (a. Id. 0(a(, (c(. If EPA finds that a chemical does not present any unreasonable risk to health or the environment, however, that finding can trigger preemption of state law regulation of the chemical. Id. (a((b(i. This is one reason that a manufacturer might ask EPA to evaluate a non priority chemical and pay for the evaluation. Cf. id. 0(b((E(ii. Second, EPA s duty to promulgate a section (a rule may arise because Congress has directed the agency to regulate that chemical. For example, Congress has directed EPA to restrict polychlorinated biphenyls (PCBs, id. 0(e, and certain persistent and bioaccumulative toxics, id. 0(h. For these chemicals, Congress has effectively substituted its own evaluation of chemical risks for a section (b risk evaluation. Finally, TSCA section allows the public to petition EPA to promulgate a section (a rule upon a showing by the petitioner that the chemical presents an unreasonable risk to health or the environment. Id. 0(a, (b((b(ii. Congress meticulously described a comprehensive process by which EPA, and if necessary the courts, should address such petitions. Reilly, 0 F.d at 0. Compared to general federal administrative law standards, section elevate[s] effective judicial review to a degree perhaps unattainable otherwise. Id. at 0. By statute, a section petition must meet two requirements. Procedurally, it must be filed in the principal office of the Administrator. U.S.C. 0(b(. Substantively, it must set forth the facts which it is claimed establish that it is necessary to issue the requested rule. Id. That is all. And while the 0 legislative amendments made small conforming amendments to section, Congress intended [n]o substantive or policy change. S. Rep. No., at (0. Once a section petition is filed with EPA, the agency has ninety days to decide whether to grant it. U.S.C. 0(b(. During that time, the agency may hold a Case No. cv 0 EMC

10 Case :-cv-0-emc Document 0- Filed 0// Page 0 of 0 0 public hearing or investigate the petition s claims. Id. 0(b(. If EPA denies the petition, the petitioner may sue to compel [EPA] to initiate a rulemaking proceeding as requested in the petition. Id. 0(b((A. A section judicial proceeding following EPA s denial of a petition for a new section (a rule is conducted de novo. Id. 0(b((B. If the petitioner persuades the court by a preponderance of the evidence that the chemical presents an unreasonable risk of injury to health or the environment... under the conditions of use, then the court shall order [EPA] to initiate the [rulemaking] action requested by the petitioner. Id. 0(b((B(ii. Case No. cv 0 EMC ARGUMENT I. Section does not require that a petition evaluate every use of a chemical Section requires a petition to set forth the facts which it is claimed establish the need for the rule. U.S.C. 0(b(. If EPA denies the petition, then the petitioner may sue. Id. 0(b(. In that suit, the petitioner must demonstrate to the satisfaction of the court, by a preponderance of the evidence, id. 0(b((B, that the chemical presents an unreasonable risk of injury to health or the environment... under the conditions of use, id. 0(b((B(ii. Nothing in this statutory scheme requires a section petition to evaluate every potential risk posed by every use of a chemical. Congress could easily have written such a requirement into section. It did not do so. EPA s contrary reading would therefore result, not [in] a construction of [the] statute, but, in effect, an enlargement of it by the court. Lamie v. U.S. Tr., 0 U.S., (00 (quoting Iselin v. United States, 0 U.S., (. Revising TSCA is Congress s job, not EPA s or this Court s. To be sure, a court in a section proceeding must determine whether the petitioner has shown the chemical poses an unreasonable risk... under the conditions of use. U.S.C. 0(b((B(ii. The phrase the conditions of use is plural and because introduced by the definite article the encompassing. See, e.g., Am. Bus Ass n

11 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 v. Slater, F.d, (D.C. Cir. 000; Kaufman v. Allstate N.J. Ins. Co., F.d, (d Cir. 00. EPA argues that this Court must therefore evaluate all the chemical s conditions of use before finding that one of them presents an unreasonable risk. But section does not require such a comprehensive inquiry (unlike EPA s section (b risk evaluation, see infra pp. ; instead, section provides that the court shall order the Administrator to initiate the action requested by the petitioner if it finds that the petitioner shows, by a preponderance of the evidence, that the chemical poses an unreasonable risk... under the conditions of use. U.S.C. 0(b((B(ii (emphasis added. A court may find an unreasonable risk without evaluating every use of the chemical. A court could, for example, find that a chemical poses an unreasonable risk of cancer when used in, say, air freshener, even if the court did not evaluate whether the same chemical also posed an unreasonable risk when used in, say, manufacturing airplane parts. The court in that scenario would have identified an unreasonable risk under the conditions of use, without necessarily identifying all possible risks under all conditions of use. TSCA does not require the court to go further. It does not require a court to evaluate every use of the chemical or indeed, any of the chemical s uses other than the one that the plaintiff contends presents an unreasonable risk. As we discuss below, this is different from EPA s obligations when preparing a comprehensive risk evaluation under section (b. II. EPA s claim that a section petition must evaluate conditions of use that the petitioner has not asked EPA to regulate is neither reasoned nor reasonable Although EPA argues that a section petition generally must address all conditions of use of a chemical, see Mot. to Dismiss 0, the agency points to no statutory language that imposes such a requirement. EPA instead attempts to hang this argument on the fact that the phrase conditions of use appears both in section (b((b, which governs judicial proceedings following EPA s denial of a rulemaking petition, and Case No. cv 0 EMC

12 Case :-cv-0-emc Document 0- Filed 0// Page of 0 section (b, which governs EPA s risk evaluations. See Mot. to Dismiss,, 0. But Congress s conforming addition of conditions of use to section is a vanishingly thin reed from which to suspend EPA s attempt to impose requirements that Congress omitted. See U.S.C. 0(b(; see also S. Rep. No., at (0 (stating that the 0 amendments to section were intended to effect [n]o substantive or policy change. EPA appears to contend that a section petition should be required to evaluate all uses of a chemical (or, at least, all uses that are not insignificant, see Mot. to Dismiss 0 because the agency s section (b risk evaluations must evaluate all (or at least some conditions of use of a chemical, see Mot. to Dismiss,. Despite considerable hand waving, however, EPA s argument is more one of policy than statutory exegesis. For while section and section (b contain some overlapping language, the two provisions are not identical, do not involve the same determinations, and serve quite different functions. When a person petitions EPA under section to issue a new section (a rule, the petition asks EPA to eliminate an unreasonable risk from a chemical by 0 Shortly before EPA denied the citizen petition at issue in this case, EPA asserted that a TSCA section (b risk evaluation must encompass all known, intended, and reasonably foreseen activities associated with the subject chemical substance. Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act: Proposed Rule, Fed. Reg., (Jan., 0 (Proposed Rule. EPA has since reversed course, announcing its belief that it may... exclude [from a section (b risk evaluation] certain activities that EPA has determined to be conditions of use in order to focus... on those exposures that are likely to present the greatest concerns. Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act: Final Rule, Fed. Reg.,,, (July 0, 0; see also Mot. to Dismiss. Amici do not believe that limiting interpretation is permissible, and have challenged it. See All. of Nurses for Healthy Env ts v. EPA, No. (th Cir. filed Aug., 0; Safer Chems. Healthy Families v. U.S. EPA, No. (th Cir. filed Aug. 0, 0 (transfer pending to th Circuit. Case No. cv 0 EMC

13 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 promulgating restrictions that remove such risk. U.S.C. 0(a. If EPA does not grant the petition, a petitioner then has a chance to demonstrate to a court that an unreasonable risk from the chemical exists. Id. 0(b((A (B. If, at the end of the section proceeding, the court finds an unreasonable risk, then the court directs EPA to initiate a section (a rulemaking to remove that risk. Id. 0(b((B. A chemical may present an unreasonable risk under its conditions of use, id., if even a single condition of use presents such a risk. EPA has recognized this. See Proposed Rule, Fed. Reg. at ( EPA recognizes that under certain circumstances it may be necessary to expedite an evaluation for a particular condition of use to move more rapidly to risk management under TSCA section (a... this could include a situation in which a single use presented an unreasonable risk of injury for the population as a whole or for a susceptible subpopulation..... But when a court rules against a section petitioner, the court does not make a finding that the chemical does not present an unreasonable risk. The court finds only that the petitioner has failed to demonstrate[] [such a risk] to the satisfaction of the court. U.S.C. 0(b((B. Risk evaluations under section (b work differently. When EPA finalizes a section (b risk evaluation, the agency must make one of two determinations: either that the chemical presents an unreasonable risk or that the chemical does not present an unreasonable risk. Id. 0(i (emphases added. This is different from a section court s determination that the petitioner has or has not not demonstrated such a risk. Id. 0(b((B. The section court s determination is critically narrower than EPA s, contra Mot. to Dismiss 0; the court, unlike EPA, never would determine that a chemical does not present an unreasonable risk. Given the broader scope of EPA s determination, Congress required EPA s risk evaluation under section (b to be comprehensive, while a court s adjudication under section is not. The finding that EPA (but only EPA may make that a chemical does Case No. cv 0 EMC

14 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 not present any unreasonable risk under any condition of use logically can be made only if all the chemical s uses are evaluated. This difference has an important legal consequence as well: an EPA finding that a chemical does not present an unreasonable risk may preempt state law restrictions of the chemical. See U.S.C. (a((b(i. The same is not true for a judicial finding that a petitioner has not demonstrated an unreasonable risk. It is thus no wonder that Congress required EPA s section (b risk evaluations to consider all of a chemical s conditions of use, while requiring a court in a section proceeding to decide the narrower question of whether the petitioner has demonstrated to the satisfaction of the court... an unreasonable risk. Id. 0(b((B (emphasis added. To the extent EPA now implies that every section (a rule must address all unreasonable risks that the chemical may present and that, therefore, a section petition must be denied unless it addresses every condition of use of the chemical, see Mot. to Dismiss the agency is arguing out of both sides of its mouth. EPA has elsewhere explained that, in a situation in which a single use presented an unreasonable risk of injury for example, where one use results in risks that EPA would determine unreasonable regardless of the risk posed by other uses EPA may move more rapidly to risk management under TSCA section (a for that condition of use. Proposed Rule, Fed. Reg. at (emphasis added; see also Final Rule, Fed. Reg. at, (July 0, 0 (reaffirming that in conducting a risk evaluation, EPA may make an early determination on one or more conditions of use. Indeed, even in denying plaintiffs section petition here, EPA stated that the amended TSCA authorizes EPA to issue TSCA section rules that are not comprehensive of the conditions of use. Fluoride Chemicals in Drinking Water; TSCA Section Petition; Reasons for Agency Response, Fed. Reg.,,,0 (Feb., 0. Piecemeal determinations that particular uses do not present unreasonable risks may overlook aggregate and cumulative risks from those different uses. For that reason, amici disagree with EPA s assertion that it can make piecemeal, early determination[s] Case No. cv 0 EMC

15 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 This makes sense: Congress would not likely have barred EPA from addressing an identified and unreasonable risk simply because EPA had not finished evaluating other, less obvious potential risks. And read carefully, EPA s motion to dismiss does not conflict with this view, for EPA asserts only that a section (a rule must eliminate any unreasonable risks that have been identified. Mot. to Dismiss (emphasis added. This assertion simply does not support EPA s conclusion that all those risks must have been identified for a section petition to succeed. III. EPA s inflated and unsubstantiated concerns about unmanageability do not justify reading additional requirements into section EPA offers two policy arguments for its revisionary reading of section, but neither survives a clear eyed examination. Even if the policy arguments were persuasive, moreover, they would not give the court power to rewrite the statute. Baker Botts L.L.P. v. ASARCO LLC, S. Ct., (0. First, Congress carefully guarded against EPA s stated worry that petitioners will promote chemicals of particular concern to them over other chemicals that may well present greater overall risk. Mot. to Dismiss. Section gives courts explicit power that a chemical does not present an unreasonable risk under particular uses before completing a full section (b risk evaluation. Final Rule, Fed. Reg. at,; see also supra n.. That concern does not arise with respect to a section petition to regulate only one use, because a court is asked only to adjudicate whether the petitioner has shown that a risk exists, not to determine that there is no risk for the chemical substance as a whole. Section (a s first clause ( If [EPA] determines in accordance with subsection (b((a... reflects that EPA s duty to issue a section (a rule typically is triggered by an EPA risk evaluation under section (b((a. U.S.C. 0(a. But as explained supra, that is not the only route to a section (a rulemaking. Under section (b, when a court finds that a chemical presents an unreasonable risk to health or the environment, the court orders EPA to promulgate a section (a rule. Id. 0(b((B. EPA acknowledges this. See Mot. to Dismiss ( [A] petition... asks EPA to jump immediately to... promulgat[ing] a regulation, without conducting a full risk evaluation.. Case No. cv 0 EMC 0

16 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 to allow EPA to defer a section (a rulemaking if the risk identified by the petitioner is less than the risks with respect to which [EPA] is taking action and EPA lacks the resources to take both sets of actions. U.S.C. 0(b((B(ii. Courts need not let section petitions push higher priority chemicals aside. Second, EPA likewise overstates the concern that petitions based on analysis of a single condition of use will force catch up risk evaluation[s] and upset EPA s orderly risk evaluation process. Mot. to Dismiss. When a court grants a section petition for a section (a rule, the court directs EPA to initiate the action requested by the petitioner, U.S.C. 0(b((B that is, to initiate a section (a rulemaking. The court does not order EPA to conduct a catch up section (b risk evaluation of uses of the chemical that are not addressed by the petition. Nor does EPA have a duty to conduct such a comprehensive section (b risk evaluation in response to a section order. Cf. supra pp.. Notwithstanding EPA s puzzling implication that section (c imposes such a duty, that subsection requires EPA to timely issue section (a rules after section (b risk evaluations, not the other way around. Compare Mot. to Dismiss, with U.S.C. 0(c(. EPA s overstated manageability concerns do not justify judicial imposition of requirements on section petitions that Congress omitted. IV. Alternatively, because section judicial review is de novo, a petition need not include all evidence the petitioner will introduce in court Even if EPA were correct (although it is not, see supra, Arguments I III that a section judicial proceeding must evaluate risks from all uses of a chemical including uses that the petitioner does not ask EPA to regulate EPA would be wrong that a section petition must include evidence evaluating those other uses. EPA s theory depends not only on its incorrect claim that a section petitioner must evaluate risks from all uses of a chemical, but also on its premise that a section judicial proceeding is limited to the administrative record. Mot. to Dismiss n.. EPA provides no support for this premise, however, other than ipse dixit. See id. Yet the premise is essential to the agency s claim that a court must dismiss a section Case No. cv 0 EMC

17 Case :-cv-0-emc Document 0- Filed 0// Page of 0 0 complaint unless the underlying petition on its face provide[s] enough information to allow... the [c]ourt to evaluate the chemical. Id. at. EPA s assumption of record review cannot be reconciled with section s de novo judicial review standard. U.S.C. 0(b((B. While judicial review under the Administrative Procedure Act (APA must, save in rare instances,... be conducted on the administrative record, section does not incorporate that standard. Reilly, 0 F.d at 0. Instead, a court proceeding under section decides for itself by a preponderance of the evidence and de novo whether TSCA s unreasonable risk standard is met. U.S.C. 0(b((B. EPA s disregard for this statutory standard and its failure to inform this Court of appellate precedent that rejects the agency s assertion that section litigations are limited to an administrative record, compare Mot. to Dismiss n., with Reilly, 0 F.d at 0 is troubling. EPA does not even try to explain why de novo in section means anything other what it normally means: a fresh, independent determination that is not limited to or constricted by the administrative record. Doe v. United States, F.d, (D.C. Cir.. Given this established meaning, appellate courts, including the Ninth Circuit, do not find error when district courts consider extra record evidence in de novo proceedings. See, e.g., Wong v. United States, F.d, (th Cir. ; see also, e.g., Saunders v. United States, 0 F.d, (th Cir.. And consistent with that meaning, TSCA s legislative history confirms that Congress understood that section plaintiffs in de novo proceedings would introduce evidence, rather than be limited to an administrative record. See S. Rep. No., at ( (stating that in a section case the court would make a decision after gathering evidence in a de novo procedure ; cf. H.R. Conf. Rep. No., at ( (stating that the de novo proceeding affords greater rights to a person petitioning for the issuance of a rule or order because in such a situation [EPA] will not previously have addressed the issue. Case No. cv 0 EMC

18 Case :-cv-0-emc Document 0- Filed 0// Page of 0 EPA s assertion that a section petition must provide all information necessary for a court to rule for the plaintiff, Mot. to Dismiss, runs headlong into the statute s de novo standard. Because a section plaintiff may introduce evidence in the court case, the underlying administrative petition need not include all the petitioner s evidence. In this sense, the petition acts more like a district court complaint than a summary judgment filing: while the petition must state the facts that the petitioner claim[s] are necessary to establish an unreasonable risk from the chemical, see U.S.C. 0(b(, the petition need not contain all the evidence supporting those claimed facts. Evidence establishing that a chemical poses an unreasonable risk may instead be submitted during a subsequent section (a rulemaking proceeding (if EPA grants the petition or in a de novo court proceeding (if EPA does not. CONCLUSION For these reasons, the Court should not read into section a requirement that a petition for a section (a rule must evaluate all of a chemical s conditions of use. // 0 Case No. cv 0 EMC

19 Case :-cv-0-emc Document 0- Filed 0// Page of 0 October, 0 Of Counsel for Safer Chemicals, Healthy Families: Robert M. Sussman 0 Garfield Street, NW Washington DC 000 Respectfully submitted, /s/ Michael E. Wall MICHAEL E. WALL (SBN 0 AVINASH KAR (SBN 00 Natural Resources Defense Council Sutter Street, st Floor San Francisco, CA 0 Tel.: ( 00 / Fax: ( mwall@nrdc.org Attorneys for Proposed Amici Natural Resources Defense Council and Safer Chemicals, Healthy Families 0 Case No. cv 0 EMC